FDA

FDA Warns Online Cigarette Retailers for Marketing Violations

In January 2013, the U.S. Food and Drug Administration (”FDA”) sent out several warning letters to online retailers of cigarettes,…

FDA Permits Marketing of Device Capable of Testing for 11 Causes of Infectious Gastroentiritis

On January 14, 2013, the U.S. Food and Drug Administration (FDA) announced that for the first time it will permit…

Court Finds FDA’s Prohibition of Off-Label Promotion Unconstitutional

On December 3, 2012, the U.S. Court of Appeals for the Second Circuit reversed the conviction of a pharmaceutical sales…

FDA Actions Highlight New Authority under FSMA

On November 26, 2012, the U.S. Food and Drug Administration (“FDA”) suspended the food facility registration of Sunland, Inc., a…

FDA Investigates Illnesses Linked to Energy Drinks and Supplements

On November 16, 2012, the U.S. Food and Drug Administration (“FDA”) issued a statement concerning the Agency’s ongoing investigation of…

Jimmy Dean Initiates Recall for Failure to Declare Allergens

On November 10, 2012, Jimmy Dean issued a Press Release, explaining how the Company is initiating a voluntary recall of…

FDA Warns Company for Marketing Medical Device

On November 5, 2012, the U.S. Food and Drug Administration (“FDA”) announced recent action the Agency has taken against a…

FDA Targets Online Pharmacies in International Efforts

On October 4, 2012, the U.S. Food and Drug Administration (“FDA”) announced that it has taken action as part of…

FDA Approves MS Drug, Noting Boxed Warnings

On September 12, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of the drug Aubagio (teriflunomide). Manufactured…

FDA Warns Dietary Supplement Firms for Marketing Concussion Treatments

On September 6, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to two dietary supplement companies in…